Exergaming Using Postural Feedback From Wearable Sensors and Exercise Therapy to Improve Postural Balance in People With Nonspecific Low Back Pain: Protocol for a Factorial Pilot Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Physical exercise is the most promising route to improvement for people with low back pain. Wearable sensors providing feedback on body movements and posture while exercising may enhance postural balance and motor control in people with low back pain. OBJECTIVE We aim to investigate whether physical exercising combined with postural feedback (EPF) improves postural balance, motor control, and patient reported outcomes in people with LBP. METHODS The study was a 2x2 factorial, assessor blinded trial. We planned to recruit 80 participants with unspecific low back pain, not receiving treatment for low back pain. In addition, we aimed to recruit 40 patients with chronic, unspecific low back pain in exercise therapy (ET) at the University Hospital Zurich. Both, patients in ET and participants without treatment were randomized to receive either an additional EPF intervention or no additional intervention. This resulted in 4 different combinations of interventions, ET + EPF, ET, EPF and no intervention. The participants underwent outcome assessments at inclusion (T1), 3 weeks later at randomization (T2), after an intervention period of 3 weeks with a predefined exercising schedule for participants receiving EPF (T3) and after additional 6 weeks, during which participants assigned to the EPF groups could exercise as much as they wished (T4). Patients receiving ET completed their regularly prescribed therapies during the study. Balance was assessed during quiet standing on a force platform and motor control during a lifting and a waiter’s bow task. Physical activity was recorded with an activity tracker and the participants’ mobile phone during the study. The predefined EPF schedule consisted of 9 sessions of 20 minutes exercising with a tablet and IMU sensors at home. Participants performed a series of trunk and hip movements and received feedback on their movements in a gamified environment displayed on the tablet. RESULTS The first participant was included in May 2019. Data collection was closed in October 2020 with 3 patients and 32 eligible people without therapy who passed the eligibility check. CONCLUSIONS Although it will not be possible to investigate differences in patients and people without other therapies, we expect this pilot study to give insights in the potential of exercising with postural feedback for improving balance in people with low back pain and adherence to such interventions. CLINICALTRIAL ClinicalTrials.gov NCT04364243 https://www.clinicaltrials.gov/ct2/show/NCT04364243